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Clinical Study on PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells

Primary Purpose

Lymphoma

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
PEG-rhG-CSF
RhG-CSF
Sponsored by
Chongqing University Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 18-65 years old, regardless of sex; Patients with lymphoma and multiple myeloma who need autologous hematopoietic stem cell transplantation; KPS score ≥70; creatinine clearance rate ≥ 50mL/min, total bilirubin level < 1.5mg/dL, ALT and AST < 2 times the upper limit of normal value; Absolute neutrophil count (ANC)≥1.5×109/L, platelet count ≥80×109/L, Hb≥ 75g/L, WBC ≥ 3.0× 109/L; Patients can tolerate chemotherapy; No active infection before chemotherapy; The patient voluntarily participated in this trial and signed the informed consent form; The researcher thinks that the subjects can benefit. Exclusion Criteria: Those who have previously received allogeneic or autologous hematopoietic stem cell transplantation; Serious or uncontrolled virus infection: HIV, syphilis positive; Severe dysfunction of internal organs; severe mental or nervous system diseases; allergic to PEG-rhG-CSF, rhG-CSF and other preparations or proteins expressed in Escherichia coli; pregnant or lactating female patients; Women of childbearing age refuse to accept contraceptive measures; Those who plan to become pregnant during the study period; The researcher judges other subjects who are not suitable to participate.

Sites / Locations

  • Chongqing University Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

experimental group

control group

Arm Description

Outcomes

Primary Outcome Measures

The proportion of patients with CD34+ cells ≥2×106/kg
The proportion of patients with CD34+ cells ≥2×106/kg

Secondary Outcome Measures

CD34+cell count
CD34+cell count
Acquisition times
The number of times a patient needs to collect a sufficient number of CD34+ cells
Mobilization time
Time interval from mobilization to collection
Hematopoietic reconstruction time after transplantation
Hematopoietic reconstruction time after transplantation
complication
complication

Full Information

First Posted
August 31, 2023
Last Updated
August 31, 2023
Sponsor
Chongqing University Cancer Hospital
Collaborators
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT06026995
Brief Title
Clinical Study on PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells
Official Title
Clinical Study on the Effectiveness and Safety of PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells for Lymphoma and Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chongqing University Cancer Hospital
Collaborators
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is a randomized controlled, open and multi-center clinical study. Patients who meet the selection criteria and do not meet the exclusion criteria are randomly given PEG-rhG-CSF with a fixed dose of 12mg when white blood cells reach the lowest point, or given rhG-CSF with a daily mobilization of 5-10μ g/kg until the collection is completed, so as to evaluate the effectiveness and safety of PEG-rhG-CSF in mobilizing autologous stem cells for lymphoma and multiple myeloma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
174 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Title
control group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
PEG-rhG-CSF
Intervention Description
Subcutaneous injection with a fixed dose of 12 mg
Intervention Type
Drug
Intervention Name(s)
RhG-CSF
Intervention Description
Inject rhG-CSF 5-10 μg/kg subcutaneously every day
Primary Outcome Measure Information:
Title
The proportion of patients with CD34+ cells ≥2×106/kg
Description
The proportion of patients with CD34+ cells ≥2×106/kg
Time Frame
28 days
Secondary Outcome Measure Information:
Title
CD34+cell count
Description
CD34+cell count
Time Frame
28 days
Title
Acquisition times
Description
The number of times a patient needs to collect a sufficient number of CD34+ cells
Time Frame
28 days
Title
Mobilization time
Description
Time interval from mobilization to collection
Time Frame
28 days
Title
Hematopoietic reconstruction time after transplantation
Description
Hematopoietic reconstruction time after transplantation
Time Frame
3 months
Title
complication
Description
complication
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-65 years old, regardless of sex; Patients with lymphoma and multiple myeloma who need autologous hematopoietic stem cell transplantation; KPS score ≥70; creatinine clearance rate ≥ 50mL/min, total bilirubin level < 1.5mg/dL, ALT and AST < 2 times the upper limit of normal value; Absolute neutrophil count (ANC)≥1.5×109/L, platelet count ≥80×109/L, Hb≥ 75g/L, WBC ≥ 3.0× 109/L; Patients can tolerate chemotherapy; No active infection before chemotherapy; The patient voluntarily participated in this trial and signed the informed consent form; The researcher thinks that the subjects can benefit. Exclusion Criteria: Those who have previously received allogeneic or autologous hematopoietic stem cell transplantation; Serious or uncontrolled virus infection: HIV, syphilis positive; Severe dysfunction of internal organs; severe mental or nervous system diseases; allergic to PEG-rhG-CSF, rhG-CSF and other preparations or proteins expressed in Escherichia coli; pregnant or lactating female patients; Women of childbearing age refuse to accept contraceptive measures; Those who plan to become pregnant during the study period; The researcher judges other subjects who are not suitable to participate.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yao Liu, doctor
Phone
132 2868 4685
Email
64823926@qq.com
Facility Information:
Facility Name
Chongqing University Cancer Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yao Liu
Phone
13228684685
Email
64823926@qq.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Study on PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells

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